The Usability, Feasibility, and Tolerability of Virtual Reality for Rehabilitation From COVID-19

NCT04505761 | Completed

• 1 other identifier: COVRehab
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

Patients who receive intensive care are known to be at high risk for physical, psychological, and cognitive impairments, a constellation known as PICS. COVID-19 patients are expected to have high chances of suffering from PICS (PICS-COV) as they frequently require several weeks of intensive care and traditional PICS preventive measures are virtually impossible due to infection control precautions, prone positioning, and deprivation of social contact. To prevent PICS after ICU discharge in COVID-19 patients, physical therapy is recommended. From recent but limited experience it appears that even patients with COVID-19 who have not been admitted to the ICU can suffer from impairments in the same domains and sometimes to a similar degree of severity. Also for these patient group rehabilitation seems warranted. Yet, the resources needed to provide rehabilitation treatment to COVID-19 patients are inadequate because healthcare systems faced a shortage of high-quality treatment for these impairments already before the COVID-19 crisis emerged. Virtual Reality (VR) provides potential to healthcare practitioners to administer fast, temporary, and tailor-made rehabilitation services at a distance, and offers a solution to address the impending surge of demand for rehabilitation after COVID-19 infection. VR consists of a head mounted display (HMD) that can bring the user by computer-generated visuals into an immersive, realistic multi-sensory environment. Current VR technology is accessible, easy in use for a large audience, and safe in use. There already exist multiple VR applications for providing physical, psychological, and cognitive rehabilitation. These applications have been brought together in a VR suite for rehabilitation after COVID-19. Patients visiting a physiotherapist for rehabilitation from COVID-19 will be asked to participate in this study. They receive a VR HMD for training purposes. This study aims to understand the usability, feasibility, and tolerability of VR for rehabilitation after COVID-19, and to pilot the effectiveness of VR improving the physical ability, mental and cognitive status of patients.

Conditions

Coronavirus; Post Intensive Care Unit Syndrome

Keywords

Virtual Reality; Rehabilitation; Post-intensive care syndrome

Outcome Measures

Primary Outcomes (3)

• Semi-structured interview with 15 patients on their experiences of VR for rehabilitation from COVID-19.

  At the end of the study, 15 patients will be interviewed about their experiences using VR for rehabilitation from COVID-19. The interview will be semi-structured, including questions on usability, tolerability and efficacy of VR according to the patients. The interviews will be recorded, written out and coded by means of grounded theory analysis in Atlas.ti. Themes and subthemes will be constructed.

  Day 42

• Use of VR

  By means of digital tracking in the VR goggles, we aim to understand what games are used most often by the participants.

  Day 42

• Semi-structured interviews with physiotherapists on their experiences of VR for rehabilitation from COVID-19.

  At the end of the study, 10 physiotherapists will be interviewed about their experiences using VR for rehabilitation from COVID-19. The interview will be semi-structured, including questions on usability, tolerability and efficacy of VR according to the physiotherapists. The interviews will be recorded, written out and coded by means of grounded theory analysis in Atlas.ti. Themes and subthemes will be constructed.

  Day 42

Secondary Outcomes (10)

• Change in baseline performance test (guidelines KNGF) - Patient specific complaints.

  Day 0, day 42

• Change in baseline performance test (guidelines KNGF) - 6 minute walk test

  Day 0, Day 42

• Change in baseline performance test (guidelines KNGF) - one-repetition maximum test

  Day 0, Day 42

• Change in baseline performance test (guidelines KNGF) - 30 sec sit to stand

  Day 0, Day 42

• Change in baseline performance test (guidelines KNGF) - Borgscale for fatigue

  Day 0, Day 42

Other Outcomes (1)

• Patient characteristics related to use of VR

  Day 0

Study Arms (1)

Intervention group

EXPERIMENTAL

Participants will receive Virtual Reality as an add-on to standard physiotherapy after COVID-19.

Device: Virtual Reality

Interventions

Virtual Reality DEVICE

Participants will use a Virtual Reality headset with a range of applications applicable for rehabilitation after COVID-19. Applications target physical, psychological, and cognitive rehabilitation. VR headset will be used for six weeks first at the physiotherapist's practice, and when possible, at home.

Intervention group

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient has had COVID-19.
• Patient has an indication for physical therapy in the context of rehabilitation after COVID-19.
• Patient is willing and able to comply with the study protocol.
• Patient is at least 16 years old on the day the informed consent form will be signed.
• Patient can read and understand the Dutch language.

You may not qualify if:

• The patient is participating in another study interfering with this study.
• Patient has difficulties to handle virtual reality:
• Patient suffers from delirium or acute confusional state.
• Patient has (a history of) dementia, seizure, or epilepsy.
• Patient has severe hearing/visual impairment not corrected.
• The skin of the patient's head or face is not intact (for example head wounds, psoriasis, eczema).
• Patient has a high risk of contamination with a therapy resistant micro-organism e.g. MRSA.
• Patients suffers from severe anxiety or depression (HADS≥16).
• Red flags (see Appendix 1).

Sponsors & Collaborators

• Radboud University Medical Center: lead

Study Sites (1)

Radboud university medical center

Nijmegen, Gelderland, 6525 GA, Netherlands

Location

Related Publications (1)

• Groenveld T, Achttien R, Smits M, de Vries M, van Heerde R, Staal B, van Goor H; COVID Rehab Group. Feasibility of Virtual Reality Exercises at Home for Post-COVID-19 Condition: Cohort Study. JMIR Rehabil Assist Technol. 2022 Aug 15;9(3):e36836. doi: 10.2196/36836.

  PMID: 35858254 DERIVED

MeSH Terms

Conditions

Coronavirus Infections; postintensive care syndrome

Condition Hierarchy (Ancestors)

Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections

Study Officials

• Harry van Goor, MD, PhD

  Radboud University Medical Center

  PRINCIPAL INVESTIGATOR

• Bart Staal, PT, PhD

  Radboud University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants are asked to use Virtual Reality as an add-on to standard physiotherapy for revalidation after COVID-19.

Study Record Dates

• First Submitted: July 3, 2020
• First Posted: August 10, 2020
• Study Start: August 1, 2020
• Primary Completion: February 1, 2021
• Study Completion: March 31, 2021
• Last Updated: April 6, 2021

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)